House debates

Monday, 9 February 2015

Private Members' Business

Medicines and Medical Devices

11:34 am

Photo of Stephen JonesStephen Jones (Throsby, Australian Labor Party, Shadow Parliamentary Secretary for Regional Development and Infrastructure) Share this | Hansard source

I second the motion. I thank the member for introducing the motion. It gives me great pleasure to second it. It gives me an opportunity to speak on the importance of health care and consumer safety in Australia.

Australia has a world-class system of health care underpinned by universal health care and Medicare, fair and affordable access to medicines through the Pharmaceutical Benefits Scheme, a quality doctor and allied health professional system underpinned by excellent training, and a safe and effective system of regulating and introducing medicines, drugs and medical devices to the market. It is one of the reasons that we have some of the best health outcomes of any developed country anywhere in the world.

For all of this to continue to occur, we require certainty. We must continually review our regulatory arrangements, but we require certainty. With the importance of certainty in mind, even today we have heard some members of the government come out and say that the GP tax—an important part, according to the government, of its budget program—is about to be dumped and other members of the government saying that it is here to stay. The people of Australia require more stability and more certainty than they are currently getting from those opposite.

Why do we regulate medicines and medical devices in this country? That is on the point of safe and effective medicines and drugs that we all rely upon. It has been the role of the Therapeutic Goods Administration to provide protections to Australians, ensuring safe and effective medicines and medical devices. And the role of the agency has evolved over many years. Prior to the 1960s, regulation tended to focus on false claims made by manufacturers of medical devices and medicines and the quality of those devices and medicines.

After the 1961 discovery of the link between thalidomide in pregnancy and the incidence of congenital abnormalities in babies—and, I should say, a delay of some five years—it was Dr Jim Forbes, the then Minister for Health, who introduced the Therapeutic Goods Bill. At that time it enjoyed bipartisan support. The bill shifted the regulation towards the efficacy and safety of products that make a therapeutic claim, as well, of course, as the manufacturing processes and their quality. Labor still believes that safety of patients and the consuming public should always be at the centre of our therapeutic goods regulatory system.

Evaluating therapeutic goods for safety, quality and efficacy can, as the member for Bennelong points out, be a costly process. But the cost of getting it wrong, whether measured in patients' lives or in the crude and unfortunate means of money, is much, much greater. So it is absolutely critical—and I do not for a moment think that the member for Bennelong, by moving this motion in the House, disagrees with me on this point—that we put patient safety and the consuming public's interests at the centre of our regulatory system. Yes, it needs to be risk based. Yes, it needs to be aligned with best practice within the international regulatory regime but it needs to have the interests of the consuming public at its centre.

The cost of getting therapeutic goods into the market can have an impact, obviously, on the final prices the patients, or indeed the Commonwealth, pays. As one of the major funders of goods listed on the Australian Register of Therapeutic Goods, the Commonwealth itself has a keen interest in this. But when things go wrong all focus attends to the consumer and not to the cost of the regulatory system. Indeed, the public is saying, 'Where was the government? How could this have been allowed to occur?' That is why we need to hasten slowly. We welcome the fact that a review has been initiated. We will not rush to judgement. We will carefully consider not only the submissions to the review but the outcomes of that review. We will form a position based on putting the interest of the consuming public first. Once again, I thank the member for Bennelong for bringing the matter before the House.

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